New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

01/18/2012

Trade Name:

Viread

Generic Name or Proper Name (*):

tenofovir disoproxil fumarate

Indications Studied:

Treatment of HIV infection in combination with other antiretroviral agents

Label Changes Summary:

*Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form